TABLE 4.
Results of the bioequivalence determination of Cefaclor granule and Cefaclor suspension in postprandial sequence.
| PK parameter | Geometric mean | GMR (%) | 90% CI (%) | %CV | Power | Result | |
|---|---|---|---|---|---|---|---|
| Cmax (ng/mL) | T (N = 24) | 1913.19 | 89.27 | 81.97–97.22 | 17.34 | 68.92 | Bioequivalent |
| R (N = 24) | 2143.11 | ||||||
| AUC0-t (h*ng/mL) | T (N = 24) | 5213.08 | 97.31 | 95.98–98.65 | 2.77 | >99.99 | |
| R (N = 24) | 5357.38 | ||||||
| AUC0-∞ (h*ng/mL) | T (N = 24) | 5257.47 | 97.31 | 95.93–98.71 | 2.88 | >99.99 | |
| R (N = 24) | 5402.92 | ||||||
T, test drug was Cefaclor granule; R, reference drug was Cefaclor suspension; PK, Pharmacokinetic; N, number of subjects; GMR, geometric mean ratios; CI, confidence Interval; CV%, within-subject coefficient of variation; AUC 0-t, the AUC of the analyte in the plasma over the time interval from time zero to the last measurable concentration; AUC0-∞, the area under the curve from 0 to infinity; Cmax, the maximum observed drug concentration in the plasma.